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Clinical Trial Details

Trial ID: L6160
Source ID: NCT03723785
Associated Drug: Insulin Icodec
Title: A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin icodec
Outcome Measures: Primary: AUCI287,0-840h,SD: Area under the serum insulin 287 concentration-time curve after a single dose, Measured in pmol\*h/L, From 0 to 840 hours after trial product administration (visit 2 (study day 1)) | Secondary: Cmax,I287,SD: Maximum observed serum insulin 287 concentration after a single dose, Measured in pmol/L, From 0 to tz hours after trial product administration (visit 2 (study day 1)), where tz is the time of the last quantifiable concentration|tmax,I287,SD: Time to maximum observed serum insulin 287 concentration after a single dose, Measured in hours, From 0 to tz hours after trial product administration (visit 2 (study day 1)).|Number of adverse events, Number of events, From trial product administration (visit 2 (study day 1)) until visit 13 (study day 43)|Change in anti-insulin 287 antibody level, Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer), From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)|Change in anti-insulin 287 antibody titres, Number of dilutions, From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)|Positive cross-reactive anti-human insulin antibodies, Number of patients with/without positive cross-reactive anti-human insulin antibodies, At visit 13 (study day 43)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-11-09
Completion Date: 2019-09-06
Results First Posted:
Last Update Posted: 2024-07-12
Locations: Charité Research Organisation GmbH, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT03723785